HYDROCORTISONE- hydrocortisone continuous spray aerosol, spray
Topco Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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1% Hydrocortisone Continuous Spray

Active ingredient

hydrocortisone 1%

Purpose

Anti-Itch

Uses

For the temporary relief of itching associated with minor skin irritations, inframtation, and rashes due to:

eczema
insect bites
poison ivy
poison oak
poison sumac
soaps
jewelry
detergents
cosmetics
seborrheic dermatitis
psoriasis
other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only.

Flammable:

Keep away from heat, sparks and open flame, Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120 F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do not use

for external genital, vaginal or anal itching
with other hydrocortisone product unless consulted by a doctor
in or near the eyes
for diaper rash

When using this product

avoid contact with eyes
if product gets into the eye, flush with water for 15 minutes

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

twist cap left to unlock actuator
adults and children 2 years of age and older:spray affected area not more than 3 to 4 times daily
children under 2 years of age:do not use, consult a doctor
to apply to face, spray into palm of hand and gently apply

Inactive ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, disodium EDTA, ethoxydiglycol, glycerin, maltodextrin, menthyl lactate, methyl gluceth-20, PEG-8, SD alcohol 40-B, sodium citrate, water

Questions?

Call 1-888-423-0139

Principal Display Panel

TOPCARE

Maximum Strength

Hydrocortisone Continuous Spray

HYDROCORTISONE 1%

ANTI- ITCH

Relieves itching from skin irritation, rashes, insect bites & poison ivy
No touch & no mess

Net WT 4.0 OZ (113g)

Top Care_Hydrocortisone Spray_50-119TC.jpg

HYDROCORTISONE
hydrocortisone continuous spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-383
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
hydrocortisone (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	hydrocortisone	1.13 g in 113 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OAT (UNII: Z6J799EAJK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ALCOHOL (UNII: 3K9958V90M)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-383-04	113 g in 1 CAN; Type 0: Not a Combination Product	12/07/2017	12/12/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/07/2017	12/12/2017

Labeler - Topco Associates LLC (006935977)

Revised: 12/2017

Document Id: 7b4693f0-dd16-4c92-b326-e86b24f7acdc

Set id: b8b9a5e5-6b47-449a-a4b2-d59b3ceb4c84

Version: 2

Effective Time: 20171212

Topco Associates LLC